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AAKP Innovator Series: AstraZeneca, Kerry Cooper, Vice President, U.S. Medical Affairs, Renal Cardio

 AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology; Cardiovascular, Renal & Metabolism; and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

 Cardiovascular, renal and metabolism together form one of AstraZeneca’s main therapy areas. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling comorbidities. Our ambition is to modify or halt the natural course of diseases that impact the heart, kidneys and pancreas, and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and organ health for millions of patients worldwide.

  Tell us about your first experience with kidney patients and what impressions that left on you as a person and as a professional.

I was fascinated by the complexity of the kidney as a medical student and quickly decided that I wanted to devote my career to helping to improve the lives of patients with chronic kidney disease (CKD). I have been able to passionately pursue this goal through direct patient care as a nephrologist, educating as a professor and now helping to provide new innovative therapies as a leader in the pharmaceutical industry. We know all too well that even today with the many advances that have come in CKD, patients still need and deserve more help in navigating the complexities of treatment management and the health care system. My journey is truly about their journey and helping them live their highest quality life. It’s the main reason I joined AstraZeneca, a company which is markedly increasing its focus on kidney diseases. I believe there is so much we can still do to innovate in this space and bring new hope to patients living with CKD and their associated comorbidities. AstraZeneca was the place to be, to be at the forefront of this science and to reach patients in new ways that can help deliver a greater future for this critical patient population.

 Explain the need for innovation in the treatment/management of anemia and hyperkalemia to help improve patient outcomes. What encouraged AstraZeneca to focus on these conditions?

AstraZeneca saw a need in general in the renal disease area. Building on their legacy of understanding cardiovascular and metabolic disease, it was clear that there was a critical space to follow the science and understand more clearly the underlying links between the heart, kidneys and pancreas. In particular, advancing and increasing evidence specific to the kidney was critical as we saw a tremendous unmet need in this population given the slow pace of innovation. We are investing across the spectrum of CKD in hopes to slow disease progression, reduce risks and tackle co-morbidities.

 In particular, two areas we saw immediate needs for the patient were in hyperkalemia and anemia. We believe in general there is a tremendous lack of awareness of both of these complications and the potential impact they can have on a patient’s overall health. Although hyperkalemia and anemia should be treated with the same medical urgency as hypertension and diabetes, the risks associated with hyperkalemia and anemia of CKD are often underappreciated and these conditions are often under treated. If hyperkalemia is left untreated it can lead to higher risk of morbidity and mortality including hospitalization, serious cardiac arrhythmias and sudden death. Similarly, inadequate treatment of anemia of CKD can have important consequences to the cardiovascular system as well as to quality of life and an individual’s ability to stay employed and contribute to society.

As an organization, we feel responsible to address this high unmet medical need and bring urgency to treat these comorbidities. Through continuous research and development of innovative medicines, we’ve been able to bring disease awareness, diagnosis and treatment for patients with hyperkalemia and anemia of CKD.

Please share how AstraZeneca’s research and development in the areas of anemia and hyperkalemia could have a significant impact on all kidney patients.

As we continue to research the use of LOKELMA™(sodium zirconium cyclosilicate https://www.azpicentral.com/lokelma/lokelma. pdf#page=1) and roxadustat on broader patient populations with hyperkalemia and anemia of CKD, we’ll be able to understand and tackle multiple unmet needs for patients and treat them along the spectrum of their disease overall. Specifically, with LOKELMA, we have been able to treat patients with hyperkalemia by increasing potassium removal from the body quickly and with sustained effects over time. For patients managing anemia of CKD, roxadustat has been shown to promote the generation of red blood cells across the spectrum of CKD by stimulating the body to produce more erythropoietin, low levels of which are the main reason for anemia in this population. In addition to research and development specifically in the areas of anemia and hyperkalemia, we are investing in research that can intervene earlier and potentially slow progression of the disease which could impact all kidney patients in improving their long-term quality of life.

 Please share how Roxadustat is different from other forms of anemia treatment?

Typically, patients with anemia of CKD are treated with erythropoietin (EPO)-stimulating agents (ESAs). EPO is a hormone produced by the kidneys that stimulates erythropoiesis by bone marrow. The loss of EPO production as kidney function declines is the principal cause of anemia of CKD. Roxadustat, is a potential first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It works differently than ESAs by mimicking the body’s natural response to low levels of oxygen and promotes red blood cell generation by increasing endogenous production of EPO. Roxadustat can be beneficial in the presence of inflammation and without a need for supplemental intravenous iron.

 Although roxadustat is still under clinical investigation in the U.S., we are very excited about the potential this drug could have on improving the lives of patients with anemia of CKD.

 There has been little advancement in the treatment of hyperkalemia for many years, more recently we are seeing this serious condition garner more attention, especially for individuals who have kidney disease – how can Lokelma help patients lower potassium levels?

 We recognized that there wasn’t much urgency around hyperkalemia, which can be a lifethreatening complication in CKD patients. LOKELMA is an innovative treatment option for patients with hyperkalemia because it lowers potassium levels in the blood by selectively capturing potassium in exchange for hydrogen and sodium. LOKELMA works differently than other potassium binders as it has a unique structure and works in the GI tract, resulting in early capture of potassium. The design of LOKELMA can reduce serum potassium levels as early as one hour after initiation of treatment with the recommended approved dose, which brings patients with hyperkalemia quick relief.

Can you share other novel approaches AstraZeneca is taking to help advance care for those with chronic kidney disease?

 Even after approval, we continue to test the optimal use of the treatments to help us reach a broader CKD patient population. For example, we recently completed a study that looked at the use of LOKELMA in patients undergoing hemodialysis, for which we saw positive results for and we are also looking at the use of LOKELMA in other patient populations and settings. Additionally, we are committed to continually bringing new science to this disease area with a goal to provide evidence on ways to ultimately slow and potential stop disease progressions, address residual risks and prevent organ damage while prioritizing and bringing new medicines to patients in the renal space quickly. We achieve this by investing in a robust clinical program that researches how our current medicines in the renal space effects a diverse range of patients living with CKD.

 As a Global leader in health care, you know well that it is not easy to develop a novel approach to treatment or enhanced care. What do you draw upon internally to keep your drive, optimism and focus on patients going at full-speed during the tough days?

As an organization, we consistently keep the patient in mind through the research and development that we do. We have a highly dedicated and committed team at AstraZeneca that really drives the optimistic atmosphere even on days when we may not see progress as quickly as we’d like to. For me personally, I’ve seen some major medical breakthroughs within my career, and I know it’s possible for treatments to keep improving. As a nephrologist who has committed my career to advancing treatment for CKD, I continue to let my passion and ambition drive me to improve the lives of patients who are dealing with such a debilitating disease. AstraZeneca is a patient-centric organization with an eye on ways we can innovate differently in the future to tackle new ways of reaching patients. This, combined with our commitment to drive science in this space, is what drives us as an organization.

By the year 2020 – what do you expect to see in terms of how care is provided to kidney patients, what immediate changes do you think can occur?

With the level of commitment AstraZeneca has devoted to increase awareness on treating the kidney and the expected advancements coming from our pipeline, I believe by 2020 we’ll live in a world where patients are diagnosed earlier – feeling empowered to understand and manage their complications more effectively and, hopefully, lowering the need for patients to be on dialysis or receiving kidney transplants.

In terms of immediate changes, we can hopefully, improve the clinical outcomes of CKD patients by providing innovative treatments like LOKELMA and continuing to advance the science for products like roxadustat. We can also continue to drive awareness on treating hyperkalemia and anemia of CKD, disease areas in which innovation in treatment has been dormant for decades. I believe all nephrologists have an imminent responsibility to have conversations with their patients regarding hyperkalemia and anemia of CKD. We must educate our patients about the severity of these comorbidities and help them understand their treatment options. By working with our partners and allies across the space, together we can advocate for the importance of continued science and awareness in the renal disease space.

It’s essential that we continue to hold ourselves accountable to make this a reality and be a catalyst of change in the industry.

Final question – AAKP believes this can reveal a lot about a person – who is one of your heroes and why?

 It is very hard for me to pick a single hero. So many of the patients I have cared for with advanced chronic kidney disease and their families are heroes to me. I am always amazed at the courage, optimism and grace that so many have demonstrated to me especially during times when I am not sure I would be able to do so. They have helped provide me with the energy and passion to continue to pursue my goal of improving the lives of those that still suffer from the consequences of kidney failure and constantly remind me that every day of good health is so precious.

Kerry Cooper MD is the US Vice President, medical affairs at AstraZeneca. A former practicing nephrologist, Dr. Cooper most recently led medical affairs in nephrology at Amgen for nearly a decade prior to joining AstraZeneca in 2018. Prior to this, he led direct patient nephrology care, with substantial experience in chronic kidney disease. He has served patients in many capacities, including his experience as a dialysis unit medical director. Dr. Cooper was trained at Yale University where he advanced to the position of associate professor of medicine

This article was originally published in aakpRENALIFE, July 2019.